LC/MS-based strategies for the confident analysis of nitrosamines
The identification and quantification of trace azido, NDSRI, and nitrosamine impurities in drug substances and products are under increased regulatory scrutiny. LC/MS-based analytical strategies can be easily adopted.
"Agilent has developed quantitative workflows that enable highly sensitive quantification of N-nitrosamine in various challenging APIs and formulation products using their LC/TQ, which can deliver detection limits even lower than those specified by the regulatory requirements.”
Dr. A. Siva Lakshmi Devi
- Case study: Read now
- Webinar: Accurate Determination of Mutagenic Azido, NDSRI and Nitrosamine Impurities Using LC-MS/MS
- Application note: Quantitation of N-Nitroso Dabigatran Etexilate Impurity